A Pharma perspective on healthcare needs and innovation in drug discovery

1
A Pharma perspective on healthcare needs and
innovation in drug discovery

• Patrick Vallance
• Head of Drug Discovery
• GlaxoSmithKline

2
A New Mindset
We need to adopt a new mindset. We in big
pharma should never take for granted our right
to exist our business model is not written into
any countrys constitution. So we should be
turning up to work every day with the mindset
that we are earning the right to exist. We are
earning it by meeting the expectations of
society. When you start to think like this, you
see the world differently.
Andrew Witty, CEO, GlaxoSmithKline Harvard,
February 2009
3
Public trust is low
Science in Society DTI MORI 2005
4
The Challenges are Significant

• In the past 20 years modern drugs have
  revolutionised the practice of Medicine and the
  outlook for patients
• The unmet need remains high
• The bar is also high
• placebo
• changing expectations
• cost
• the public health agenda

5
Fabrys Disease

• Pain throughout the body
• Impaired sweating
• Heat/cold intolerance
• Skin rashes (angiokeratomas)
• Corneal whorling
• Hearing problems
• Gastrointestinal problems
• Heart problems
• Kidney problems
• Nervous system problems
• Psychological issues

6
Large improvement in pain in Fabrys Disease
7
Large improvement in pain in Fabrys Disease
Placebo
Active
8
The Challenges are Significant

• In the past 20 years modern drugs have
  revolutionised the practice of Medicine and the
  outlook for patients
• The unmet need remains high
• The bar is also high
• placebo
• changing expectations
• cost
• the public health agenda

9
RD for a New Medicine 10 years, 1 bn
a big challenge for addressing both developed
and developing world diseases
RegulatoryReview
Drug Discovery
Scale-Up to Manufacture
Post-MarketingSurveillance
Preclinical
Clinical Trials

PhaseIII
PhaseI
Phase II
5,000 10,000
250
5
1Approved NewMedicine
Compounds
Pre-Discovery
IND Submitted
NDA Submitted
Number Of Patients / Subjects
20 100
100 500
1,000 5,000
0.5 2 Years
Indefinite
6 7 Years
3 6 Years
Sources Drug Discovery and Development
Understanding the RD Process, www.innovation.org
CBO, Research and Development in the
Pharmaceutical Industry, 2006
10
RD Productivity Gap
Source Burrill Company US Food and Drug
Administration. Note NMEs do not include BLAs
11
The realities of having the best pipeline
Lehman Brothers PharmaPipelines (Sept
2007) Pharma Replacement Power NPV
GlaxoSmithKline Merck Bristol Myers
Squibb Novartis Johnson Johnson Sanofi-Aventis A
straZeneca Pfizer Wyeth Eli Lilly Roche Abbott
Labs Schering Plough AVERAGE
LB Method NPV of recent launches (06-07) NPV
of pipeline opportunities from 08-13 / NPV of
products marketed before 2006.
12
RD for a New Medicine 10 years, 1 bn
a big challenge for addressing both developed
and developing world diseases
RegulatoryReview
Drug Discovery
Scale-Up to Manufacture
Post-MarketingSurveillance
Preclinical
Clinical Trials

PhaseIII
PhaseI
Phase II
5,000 10,000
250
5
1Approved NewMedicine
Compounds
Pre-Discovery
IND Submitted
NDA Submitted
Number Of Patients / Subjects
20 100
100 500
1,000 5,000
0.5 2 Years
Indefinite
6 7 Years
3 6 Years
Sources Drug Discovery and Development
Understanding the RD Process, www.innovation.org
CBO, Research and Development in the
Pharmaceutical Industry, 2006
13
A disconnect between discovery and invention?
Scientific publications in biomedicine
The opportunity has never been greater
14
Reintroduce Scientific Judgement
15
Evolution From Monolith
External Resources
Virtualization of Drug Discovery
Pharma
Internal Resources
Centralized Control/Management
De-Centralized Control/Management
16
How should we choose where to invest discovery
effort?
External
Internal
Scientific Opportunity
Market size
Pipeline strength Organisational structure
Patient need
17
The Market
2006 Estimated Global Sales
90,000
80,000
The Lehman Brothers analysis of predicted global
sales for 2006 does not include generic drugs and
estimates that their database captures 80 of
branded drug sales.
70,000
60,000
50,000
Global Sales m
40,000
76,850
65,275
30,000
43,928
39,910
20,000
26,875
19,481
18,808
10,000
17,793
15,337
11,549
0
CNS
Cancer
Diabetes
Respiratory
Inflammation
Dermatology
Haematology
Genito-Urinary
Immune System
Ophthalmic Drugs
Sexual Dysfunction
Metabolism/Endocrinology Drugs
Diabetes, cancer and inflammation projected to be
the biggest growth opportunities
Source Pharma Pipelines Strategic Analysis and
Conclusions 2006 Lehman Brothers
18
Public Funding
19
How should we choose where to invest discovery
effort?
External
Internal
Scientific Opportunity
Market size
Pipeline strength Organisational structure
Patient need
20
Small integrated, empowered teams
21
Pharma partnerships
New/expanded in 2008/2009 YTD
35 external engines
35 internal engines
Corporate Venture Fund
22
RD for a New Medicine 10 years, 1 bn
a big challenge for addressing both developed
and developing world diseases
RegulatoryReview
Drug Discovery
Scale-Up to Manufacture
Post-MarketingSurveillance
Preclinical
Clinical Trials

PhaseIII
PhaseI
Phase II
5,000 10,000
250
5
1Approved NewMedicine
Compounds
Pre-Discovery
IND Submitted
NDA Submitted
Number Of Patients / Subjects
20 100
100 500
1,000 5,000
0.5 2 Years
Indefinite
6 7 Years
3 6 Years
Sources Drug Discovery and Development
Understanding the RD Process, www.innovation.org
CBO, Research and Development in the
Pharmaceutical Industry, 2006
23
Leading the pack ATM Index
Source Access to Medicines Index (Innovest)
24
DDW Partners Tres Cantos